Business Wire, Dec 08, 2009
PARIS — Neovacs, a biotechnology company developing proprietary immunotherapies
for autoimmune and chronic diseases, today announced the initiation of a
Phase IIa clinical study of its TNF Kinoid immunotherapy in rheumatoid
arthritis patients who have ceased to respond to an anti-TNF monoclonal
antibody and who test positive for anti-drug antibodies (ADAs). The
announcement follows trial clearance by the French regulatory authority
(AFFSAPS) and the central ethics committee. Neovacs has also submitted
the trial protocol to the relevant authorities in two other European
countries and has already received regulatory clearance in one and
ethics committee approval in the other.
This is a major milestone and an excellent way to end 2009 a year
that has seen Neovacs make significant progress, stated Guy-Charles
Fanneau de la Horie, CEO of Neovacs, Along with the ongoing Phase Ib
trial in Crohns patients, this new Phase IIa trial adds a second
indication for our TNF-Kinoid. We also plan to initiate clinical testing
of our second product, IFN Kinoid, in early 2010.
The Phase IIa study, to be performed in collaboration with the
diagnostics company BMD, is part-financed by significant funding from
OSEO/ISI, the French state innovation agency
rituxan rheumatoid arthritis